Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-02 @ 1:29 AM
Study NCT ID:
NCT06634732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Ultrasound Assessment of Abdominal Cavity Space
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-20, higher scores indicate a worse outcome'}, {'measure': 'Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-20, higher scores indicate a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Time to initiate enteral nutrition', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'Time to initiate enteral nutrition after admission to ICU in hours'}, {'measure': 'Intra-abdominal pressure', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'Intra-abdominal pressure in mmHg'}, {'measure': 'C-reactive protein', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'C-reactive protein in mg/L'}, {'measure': 'procalcitonin', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'procalcitonin in ng/L'}, {'measure': 'white blood cell count', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'white blood cell count'}, {'measure': 'time to achieve enteral nutrition targets', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'time to achieve enteral nutrition targets in hours'}, {'measure': 'serum albumin', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'serum albumin in g/L'}, {'measure': 'prealbumin', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'prealbumin in mg/L'}, {'measure': 'Duration of Continuous Renal Replacement Therapy treatment', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'Duration of CRRT (Continuous Renal Replacement Therapy) treatment in hours'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'duration of mechanical ventilation in hours'}, {'measure': 'length of ICU stay', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'length of ICU stay in days'}, {'measure': 'prognosis', 'timeFrame': 'up to 28 days after admission to ICU', 'description': 'survival or death when transfer out of the ICU'}, {'measure': 'acute physiology and chronic health evaluation II score', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-71, higher scores indicate a worse outcome'}, {'measure': 'Sequential Organ Failure Assessment', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-15, higher scores indicate a worse outcome'}, {'measure': 'Abdominal Gastrointestinal Index score', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-4, higher scores indicate a worse outcome'}, {'measure': 'Abdominal Gastrointestinal Index Ultrasonography Score', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-10, higher scores indicate a worse outcome'}, {'measure': 'Gastrointestinal Ultrasound Scoring score', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-10, higher scores indicate a worse outcome'}, {'measure': 'semi-quantitative ultrasound score of gastric content', 'timeFrame': 'up to 3 days after admission to ICU', 'description': 'score range from 0-2, higher scores indicate a worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'MODS', 'Shock']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study to observe the diagnostic efficacy of a quantitative ultrasound assessment plan for pathological accumulation in the abdominal cavity space of critically ill patients, and to explore its correlation with patient clinical outcomes.', 'detailedDescription': 'Intra-abdominal lesions, such as hemorrhage and inflammation/infection, often lead to pathological accumulations, posing serious challenges for critically ill patients. These lesions can rapidly induce intra-abdominal hypertension and organ damage, which may progress to hemorrhagic or septic shock, endangering patients\\' lives. Intra-abdominal hemorrhage, especially surgery-related hemorrhage, is difficult to detect early, and existing assessment methods like CT scans have limited applicability in critically ill patients. Intra-abdominal infections account for a high proportion of infections in critically ill patients, with concurrent sepsis or shock having high mortality rates. Despite advancements in critical care medicine, the mortality rate from intra-abdominal infections remains stubbornly high. Accurate assessment of the source and extent of infection is crucial for treatment, yet routine physical examinations have low sensitivity in critically ill patients, making imaging examinations the primary method. However, while abdominal CT is considered the gold standard, it is limited by insufficient dynamic monitoring and difficulties in patient transport. Bedside ultrasound plays a significant role in the monitoring of critically ill patients due to its portability, non-invasiveness, and real-time dynamic capabilities. It can assess sources of hemorrhage and infection, quantify the extent of lesions, and monitor hemodynamic changes. Therefore, this study aims to develop a comprehensive ultrasound assessment protocol that covers the peritoneal cavity and posterior peritoneal space. Through a prospective observational study, we aim to validate its sensitivity and specificity in diagnosing pathological accumulations such as intra-abdominal hemorrhage/infection and explore its correlation with patient clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients in the Department of Critical Care Medicine at Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old;\n* Expected ICU stay ≥ 72 hours;\n* Meeting one of the diagnostic criteria for intra-abdominal infection: 1) Single organ infection (such as cholecystitis, appendicitis, diverticulitis, cholangitis, pancreatitis, salpingitis, etc.), which may be accompanied by or without peritonitis, even without perforation; 2) Peritonitis, classified as primary, secondary, or recurrent; 3) Intra-abdominal abscess.\n\nExclusion Criteria:\n\n* Patients with wounds, redness, swelling, bleeding, or other conditions at the abdominal measurement points that prevent ultrasound assessment;\n* Patients with intra-abdominal gas accumulation that affects abdominal ultrasound imaging, making ultrasound quantitative scoring impossible;\n* Patients who have not undergone abdominal CT examination within 72 hours of ICU admission;\n* Patients who do not consent to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06634732', 'briefTitle': 'Quantitative Ultrasound Assessment of Abdominal Cavity Space', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Study on the Application Value of Quantitative Ultrasound Assessment Plan for Abdominal Cavity Space in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'ZWQ21886-2024-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observational group', 'description': 'Subjectives will undergo abdominal ultrasound examination immediately after receiving an abdominal CT scan.after admission to the ICU.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'weiqing Zhang, Ph.D', 'role': 'CONTACT', 'email': 'weiq.zh@163.com', 'phone': '8618521525300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}